Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K080607 |
Device Name |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50416 |
INDIANAPOLIS,
IN
46250 -3831
|
|
Applicant Contact |
KATHIE J CUNNINGHAM |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50416 |
INDIANAPOLIS,
IN
46250 -3831
|
|
Correspondent Contact |
KATHIE J CUNNINGHAM |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 03/04/2008 |
Decision Date | 05/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|